85/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
Carbamazepine Adverse Events: High Seriousness and Diverse Reactions
124,512 FDA adverse event reports analyzed
Last updated: 2026-05-12
CARBAMAZEPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 124,512 FDA adverse event reports, CARBAMAZEPINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CARBAMAZEPINE include DRUG INEFFECTIVE, SEIZURE, DRUG INTERACTION, FALL, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CARBAMAZEPINE.
Carbamazepine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 124,512 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Drug Ineffective, Seizure, Drug Interaction. Of classified reports, 86.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Seizures and falls are common and serious adverse events.
Drug interactions and ineffective drug performance are frequent. Psychiatric adverse events, including depression and suicidal ideation, are notable.
Patients taking Carbamazepine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Carbamazepine can cause drug interactions, and patients should be warned about potential interactions with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Carbamazepine received a safety concern score of 85/100 (high concern). This is based on a 86.0% serious event ratio across 65,266 classified reports. The score accounts for 124,512 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 34,467, Male: 24,509, Unknown: 376. The most frequently reported age groups are age 52 (996 reports), age 77 (979 reports), age 50 (851 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 65,266 classified reports for CARBAMAZEPINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Carbamazepine can cause drug interactions, and patients should be warned about potential interactions with other medications.
If you are taking Carbamazepine, here are important things to know. The most commonly reported side effects include drug ineffective, seizure, drug interaction, fall, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of depression and suicidal ideation, especially during the initial weeks of treatment. Be cautious of potential drug interactions and inform healthcare providers of all medications being taken. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety.
The FDA has received approximately 124,512 adverse event reports associated with Carbamazepine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Carbamazepine include Drug Ineffective, Seizure, Drug Interaction, Fall, Dizziness. By volume, the top reported reactions are: Drug Ineffective (4,900 reports), Seizure (3,609 reports), Drug Interaction (3,371 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Carbamazepine.
Out of 65,266 classified reports, 56,113 (86.0%) were classified as serious and 9,153 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Carbamazepine break down by patient sex as follows: Female: 34,467, Male: 24,509, Unknown: 376. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Carbamazepine adverse events are: age 52: 996 reports, age 77: 979 reports, age 50: 851 reports, age 55: 791 reports, age 58: 787 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Carbamazepine adverse event reports is Novartis Pharmaceuticals Corporation. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Carbamazepine include: Pyrexia, Nausea, Toxicity To Various Agents, Off Label Use, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Carbamazepine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Carbamazepine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Seizures and falls are common and serious adverse events.
Key safety signals identified in Carbamazepine's adverse event data include: Seizures and falls are among the most reported serious adverse events.. Drug interactions and ineffective drug performance are significant safety signals.. Psychiatric adverse events, including depression and suicidal ideation, are common.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Carbamazepine can cause drug interactions, and patients should be warned about potential interactions with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Carbamazepine.
Monitor patients for signs of depression and suicidal ideation, especially during the initial weeks of treatment. Be cautious of potential drug interactions and inform healthcare providers of all medications being taken.
Carbamazepine has 124,512 adverse event reports on file with the FDA. Drug interactions and ineffective drug performance are frequent. The volume of reports for Carbamazepine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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